Evaluación del Uso de Bolsas de Plástico para Prevenir la Hipotermia Neonatal-Parte I
Evaluación aleatoria del uso de bolsas de plástico para prevenir la hipotermia neonatal en países en desarrollo - Parte I
The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part I is for preterm/low birth weight infant with or without plastic head cover used during resuscitation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will compare the incidence of hypothermia during the first hour after birth in preterm/low birth weight infants randomized to receive WHO thermoregulation care and a plastic bag (without drying) covering the torso and lower extremities (control group) or WHO thermoregulation care and a plastic bag (without drying) covering the torso, upper and lower extremities, and a portion of their head (intervention group). The axillary temperature of each infant will be taken initially within 15 minutes of birth and later at 1 hour after birth as the infant is removed from the plastic bag. Seizures, hyperthermia, room temperature, and death will be recorded throughout the hospitalization for all infants. With an estimated baseline hypothermia rate of 41% and a 21% absolute risk reduction (51% relative risk reduction), a sample size of 182 will be used to have a power of 80% and a confidence interval of 95%.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lusaka, Zambia
- University Teaching Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Estimated gestational age 29-36 6/7weeks or birth weight 1,400-2500g
- Delivery in the hospital
Exclusion Criteria:
- Infant admitted to the NICU
- Birth weight less than 1,400g
- Abdominal wall defect or myelomeningocele
- Major congenital anomalies
- Blistering skin disorder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Resuscitation-torso plastic bag
Resuscitation with plastic bag covering torso and lower extremities for first hour to assist with temperature regulation. |
Infant's extremities and torso will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. |
|
Comparador activo: Resuscitation-partial-head plastic bag
Resuscitation with plastic bag covering torso, upper and lower extremities, and a portion of the head for first hour after birth to assist with temperature regulation. |
Infant's torso, extremities, and portion of the head (face will be exposed) will be placed in a plastic bag during resuscitation after birth and maintained for 1 hour after birth. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Axillary temperature < 36.5 degrees Celsius
Periodo de tiempo: 1-72 hours after birth
|
Temperature taken per axilla at one hour after birth. Temperatures 36.0-36.4 will be classified as mild hypothermia, 32.0-35.9 will be classified as moderate hypothermia, and < 32.0 will be classified as severe hypothermia |
1-72 hours after birth
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Seizure
Periodo de tiempo: Up to 4 weeks
|
Seizure activity diagnosed by medical doctor or nurse. No electroencephalogram will be done. |
Up to 4 weeks
|
|
Respiratory Distress Syndrome (RDS)
Periodo de tiempo: Up to 4 weeks
|
Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant |
Up to 4 weeks
|
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Pneumothorax
Periodo de tiempo: Up to 4 weeks
|
Either chest radiograph documentation or clinical deterioration consistent with air leak |
Up to 4 weeks
|
|
Sepsis
Periodo de tiempo: Up to 4 weeks
|
Culture proven or culture negative clinically treated course consistent with sepsis |
Up to 4 weeks
|
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Necrotizing enterocolitis or intestinal perforation
Periodo de tiempo: Up to 4 weeks
|
Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's classification stage greater than one. |
Up to 4 weeks
|
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Death
Periodo de tiempo: Up to 4 weeks
|
Cardiorespiratory failure |
Up to 4 weeks
|
|
Hyperthermia
Periodo de tiempo: Up to 4 weeks
|
Axillary temperature > 38 degrees Celsius per temperature taken per axilla for one minute |
Up to 4 weeks
|
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Temperature and humidity
Periodo de tiempo: 1-72 hours after birth
|
A recording of the room temperature and humidity will be obtained with each axillary temperature measurement |
1-72 hours after birth
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Waldemar A Carlo, MD, University of Alabama at Birmingham
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimado)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UAB Neo 005
- Perinatal Health/Human (Otro identificador: University of Alabama at Birmingham)
- Childrens Centennial (Otro identificador: Childrens of Alabama)
- Caduceus Club (Otro identificador: University of Alabama School of Medicin)
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